The Function of Nutrition Rich Vegan Drink on Inflammatory Bowel Disease

January 25, 2022 updated by: Per Bendix Jeppesen

The aim of this project, would be to develop a new formula, with high nutrition content on a vegan basis. The investigators expect to produce this novel vegan-based juice product, which does not exist on the marked today. The juice would consist of different selected varieties of vegetables and fruits. Beside the vegetables, the juice will also contain plant oils to increase the calorie level, as well as a protein sources containing amino acids with high anabolic effects.

The products will be tested in an intervention study on patients with inflammatory bowel disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Between 18 and 85 years old
  • Diagnosed with or show signs of UC or Crohns disease
  • Mild symptoms i.e intestinal symptoms
  • Has had the same medicin the previous week before starting in the study

Exclusion Criteria:

  • Food or vegetable allergi
  • Cognitive diseases e.g alzheimers or dementia
  • Has diabetes requiring insulin or GLP-1 analog treatment (NB: No does include T2D patients, taking tablets or other diabetes therapy)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vegan drink
Treatment group
Dietary supplement: Vegan drink
Vegan based drink containing vegetables, fruits and plant oils. Dose: 500 mL a day
Placebo Comparator: Control
Placebo group
Dietary supplement: Control
Placebo drink Dose: 500 mL a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory factors
Time Frame: 3 weeks
F-calprotectin
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Per Bendix Jeppesen

Collaborators

Future Food Innovation

Investigators

  • Principal Investigator: Per B Jeppesen, Prof, Department of clinical medicin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2020

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

February 21, 2019

First Submitted That Met QC Criteria

March 5, 2020

First Posted (Actual)

March 6, 2020

Study Record Updates

Last Update Posted (Actual)

February 1, 2022

Last Update Submitted That Met QC Criteria

January 25, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VEGJUICE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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